Elongated endoluminal devices, such as guide wires and catheters are tubular medical devices for insertion into canals, vessels, passageways, or body cavities; often to permit the injection or withdrawal of fluid, to keep a passage open, to take internal measurements, image the vessel from the interior, deliver energy to treat the vessel, among many possible uses. While catheters and guide wires vary in size, shape, and function, they frequently consist of a very long, flexible, and thin tubular portion connected to a more rigid proximal portion. The tubular portion may be a meter or longer in length, and only a fraction of an inch in diameter. The head may be, for example, an inch or two in length and a fraction of an inch in diameter.
The tubular portion of the catheter is usually hollow, and may have one or more lumens running along its entire length. The lumen or lumens function as a way of inserting various devices into the catheter. For example, catheters frequently travel along a guide wire running through one of the lumens. Alternatively, the lumens may receive mechanical devices, control wires, electrical connectors or wires, optical fibers or other devices for assisting in diagnostic, therapeutic or surgical operations.
Due to the extremely fine and often delicate nature of the lumens and electrical connections, as well as the tight tolerances associated with many of the applications to which devices are applied, devices must necessarily be handled, stored, and shipped with great care. Mechanical or chemical abrasion to any portion of the exterior of the device can cause problems to the subsequent use of the device. Also, deformation of the device can be a problem if it results in leaving the device damaged or transformed in any way. Thus, significant bending of the device should normally be avoided during the storage of a device to avoid any “memory” of the bend, pinched lumens, or broken electrical connections. Such binding should also be avoided while installing or removing a device from a storage or shipping package.
Referring now to FIG. 1, there is shown an existing packaging system 100. Protective sheath tubing 102 is wound in a spiral fashion around center 108. A luer lock 104 is positioned on the outermost termination and can be used for flushing the tubing 102. The spiral tubing has an outer radius 110 of approximately 4.5 inches, with an outer diameter of approximately 9 inches, and spirals inward to an inner radius 112 of approximately 3.6 inches at inner most termination 106. A pressure sensing guide wire 114 is disposed within the tubing 102 and exits at termination 106. The pressure wire 114 continues inward sharply to the entry of coupler 120 disposed at a radius 116 of approximately 3.2 inches. Given the short distance between the termination 106 of tube 102 and the connector 120, the wire experiences a sharp bending radius of approximately 1.75 inches adjacent curve 124 which is adjacent electrical connectors disposed within the connector 120.
Unfortunately, for some types of devices, such as sensitive pressure wires, positioning during packaging and handling during shipping cause damage to the guide wire and/or the associated electrical connections. As a result, the pressure wires are inoperable or inaccurate when an attempt is made to introduce them into the patient on the operating or catheter lab table.
Thus, there remains a need for packaging systems and techniques that can limit damage to delicate elongated endovascular devices. The devices, systems, and methods disclosed herein overcome one or more of the deficiencies of the prior art.